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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Mar 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
no bacteria strain included to detect cross-linking mutagens
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
5-hydroxy-15β,16β-methylene-3β-pivaloyloxy-5β-androst-6-en-17-one
EC Number:
617-345-3
Cas Number:
82543-14-4
Molecular formula:
C25H36O4
IUPAC Name:
5-hydroxy-15β,16β-methylene-3β-pivaloyloxy-5β-androst-6-en-17-one
Details on test material:
- Name of test material (as cited in study report): ZK 90504
- Batch No.: 21608604

Method

Target gene:
Histidine gene locus
Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 100, TA 1537, TA 1538, TA 98
Metabolic activation:
with and without
Metabolic activation system:
liver S9-mix from Aroclor 1254 -treated rats
Test concentrations with justification for top dose:
Enpivalat: six concentrations from 0.1 to 5 mg/plate
Sodium azide: 5 µg/plate (TA 1535 and TA 100, without S9 mix)
2-Nitrofluorene: 10 µg/plate (TA 1538 and TA 98, without S9 mix)
4-Nitro-o-phenylenediamine: 10 µg/plate (TA 1537, without S9 mix)
Benzo[a]pyrene: 2.5 µg/plate (TA 100 and TA 98, with S9 mix)
Cyclophosphamide: 400 µg/plate (TA 1535, with S9 mix)
2-Aminoanthracene: 2 µg/plate (with S9 mix)
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: Sodium azide (TA 1535 and TA 100, -S9 mix), 2-Nitrofluorene (TA 1538 and TA 98, -S9 mix), 4-NPDA (TA 1537, -S9 mix), Benzo[a]pyrene (TA 100 and TA 98, + S9 mix), Cyclophosphamide (TA 1535, +S9 mix), 2-Aminoanthracene (+S9 mix)

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium strains TA 1535, TA 100, TA 1537, TA 1538, TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
Growth inhibition was observed at the highest dose tested. Precipitates in the agar were found starting at 2.5 mg/plate onwards.
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Executive summary:

Enpivalat was tested in the Salmonella/microsome test for point-mutagenic effects in doses up to 5000 µg/plate on the five histidine-auxotrophic Salmonella typhimurium LT2 strains TA 1535, TA 100, TA 1537, TA 1538 and TA 98.

A cytotoxic effect was seen at the highest dose tested (5 mg/plate). Precipitates in the agar were also detectable starting at 2.5 mg/plate.

There was no evidence for a mutagenic activity of Enpivalat, when tested up to the highest recommended dose level of 5.0 mg/plate in the absence and presence of S9 mix.